Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty

NCT03396640 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-10-23

No results posted yet for this study

Summary

In treatment of isolated medial unicondylar osteoarthritis of the knee (MU-OA), it is possible to choose between surgery with a unicondylar knee arthroplasty (UKA), or a total knee arthroplasty (TKA).

Supporters of TKA suggest that this treatment gives a more predictable and better result, whereas supporters of UKA suggest that it is unnecessary to remove decent and functional cartilage in other compartments, and also that generally the UKA gives better results under certain circumstances. If the UKA is worn out or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be much more problematic.

Also, it is of great interest to measure the direct costs of these treatments. Both general hospital costs, but also costs in societal in terms of sick-days, pain-killer expenditure, and physiotherapy.

The aim of this study is to compare the results, in terms of 1) patient-reported outcomes, 2) clinical results including prosthetic survival and 3) costs.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

Unicondylar Knee Arthroplasty

Incision will be midline incision, as with a TKA, for maximum security of blinding. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.

PROCEDURE

Total Knee Arthroplasty

Incision will be midline incision, as standard. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.

Sponsors & Collaborators

  • Naestved Hospital

    collaborator OTHER
  • Vejle Hospital

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • Svendborg Hospital

    collaborator OTHER
  • Bispebjerg Hospital

    collaborator OTHER
  • Randers Regional Hospital

    collaborator OTHER
  • Regionshospitalet Silkeborg

    collaborator OTHER
  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Anders Odgaard, Consultant · Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2041-10-16
Completion
2041-10-16

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396640 on ClinicalTrials.gov